Evaluation of Prolonged Asparaginase Activity Levels After Calaspargase Pegol Administration

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07221656
Status
Not Yet Recruiting

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Conditions

  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional Study — OTHER
    Non-interventional study

Study Details

This study evaluates the median duration of therapeutic serum asparaginase activity (SAA) levels after administration of calaspargase pegol (Cal-PEG) and the potential association between peak SAA levels and duration of therapeutic levels with toxicity in pediatric patients with acute lymphoblastic leukemia or lymphoma.

Key Dates

Start date
Feb 1, 2027
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Observational
    Patients provide blood samples collected during regularly scheduled appointments and have medical records reviewed throughout the study.

Primary Outcome Measure

Duration of therapeutic SAA [ Time Frame: Up to 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Pediatric Research
507-266-2942
Madeleine B. O'Keefe, MD (PRINCIPAL_INVESTIGATOR)

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